Amjevita (adalimumab-atto) NDC 84612-481

Product information

Brand name (proprietary)

Amjevita

Generic name (nonproprietary)

adalimumab-atto

Active ingredients

Adalimumab — 80 mg/.8mL

Dosage form

Injection

Route

Subcutaneous

Labeler

Nuvaila Limited

Product type

Prescription drug

Marketing category

BLA — Biologics License ApplicationApplication BLA 761024

Marketing start

Jan 1, 2025

Listing expires

Dec 31, 2027

Other FDA classes

Monoclonal (Chemical structure)Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)

Identifiers

Product ID 84612-481_58e52f3d-5688-461e-99e5-bdb98026f21aSPL ID 58e52f3d-5688-461e-99e5-bdb98026f21aSPL set ID d7862491-2634-4402-b001-dcc1abf8dd58RxCUI 2663901, 2663904, 2663906, 2663907, 2663908, 2663910, 2663914, 2663915UNII FYS6T7F842UPC 0384612399012, 0384612479028

Pharmacologic class

Tumor Necrosis Factor Blocker

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeMed-Code curated

J0135 — Injection, adalimumab, 20 mg

Billing unit: 20 mg. Units on the claim = dose given ÷ 20 mg.

Adalimumab is usually self-administered and dispensed through a pharmacy benefit. Adalimumab biosimilars are listed under their own names.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N484612048101 followed by a unit qualifier and the quantity Copy

Package 84612-0481-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Other NDCs under BLA 761024

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.